The present invention relates to the health field, and more particularly to a device for protecting workers, such as morgue and funeral home personnel, from blood and other body-fluid borne pathogens, as well as noxious odors, that may be emitted from corpses, particularly in autopsy and embalming settings.
Historically, the optimum criteria for precautionary infection control measures in postmortem settings were established out of concern for the potential infection of technical personnel by the hepatitis B virus (HBV). Hepatitis B, formerly known as serum hepatitis, is still the primary infection hazard of the health industry and funeral industry. However, since acquired immune deficiency syndrome (AIDS) was recognized as a public health problem in 1981, its infection potential has also become a very serious consideration.
In the United States, the principle mode of transmission of the HBV in the general population is sexual (homosexual and heterosexual). It is also transmitted by the shared needles of intravenous drug users. As it is a blood-borne virus, health care workers and other workers who are exposed to blood and body fluids are considered at risk for HBV infection.
In spite of vaccines against the HBV, the Center for Disease Control in Atlanta, Georgia (CDC) has recently reported that hepatitis B infection is steadily increasing in the United States with a possible 300,000 persons becoming infected annually. There are unpublished estimates of 500-600 annual hospitalizations of health-care workers who have become infected through exposure to blood, with over 200 deaths. (Morbidity and Mortality Weekly Report, p. 4, Aug. 21, 1987). The CDC believes that as many as 18,000 health-care workers may be infected annually with 10 percent of these becoming carriers. This unknown factor increases the risk for all workers exposed to blood and body fluids.
The AIDS virus has been called AIDS-associated retrovirus (ARV), human T-lymphotropic virus III (HTLV-III), lymphadenopathy-associated virus (LAV) and a combination of the last two (HTLV-III/LAV). Human immunodeficiency virus (HIV) is now the preferred term. Essentially, the epidemiology and disease transmission of the HIV is similar to those of the HBV. The HIV has a long and varied incubation period and can remain stable in dried blood for several days. It has been isolated from many body fluids and secretions, but like the HBV, it is primarily a blood-borne, sexually-transmitted disease.
Recent CDC statistics estimate 1.5 million HIV-infected persons in the general population of this country, though only 40,000 cases had been reported by August, 1987. It is estimated that there is a larger percentage of undiagnosed carriers of HIV than HBV. The number of reported cases is expected to increase to as many as 270,000 by 1991, and the CDC has declared AIDS an epidemic. As the number of people who are infected with the virus and the number of actual AIDS cases increases, the potential for exposure to workers at risk will also rise. Infection with the HIV is now considered to be small in comparison with HBV. However, any risk at all must be taken seriously because no drug has been developed to cure AIDS, and there is no vaccine to prevent it.
In addition to the HBV and HIV, there are many other blood-borne pathogens that merit concern in any consideration of infection potential. Some of these are hepatitis non-A and non-B, leptospirosis, malaria, rat-bite fever, relapsing fever, syphilis (primary and secondary stages), arthropod borne viral fevers such as Colorado tick fever, babesiosis and Creutzfeldt-Jakob disease.
In view of the possible risks and the present inability of medical assessment and examination to identify all patients infected with blood-borne viruses, especially HIV, the most recent CDC guidelines direct that all patients are to be considered infectious and that all autopsies are to also be considered infectious. "Universal precautions" or "universal blood and body fluid precautions" are terms coined by the CDC to describe a situation where protective barrier precautions are used in handling blood and body fluids from all patients. The use of gloves, waterproof clothing and other such items to prevent skin and mucous-membrane contact with blood or body fluids, and precautions to avoid injuries from needles and other sharp objects that could introduce infection into the bloodstream are primary components of universal precautions.
Other organizations are also involved in offering proposals for infection control and protection of health care workers. Among these are the National Committee for Clinical Laboratory Standards (NCCLS), the American Hospital Association (AHA) and the Labor Department's Occupational Safety and Health Administration (OSHA). Whatever their differences, all agree that protective barriers and special precautions are necessary for workers exposed to blood and body fluids. The OSHA proposal even includes the inspection of health-care facilities and fines for failure to enforce guidelines for the protection of health care workers.
Personnel performing postmortem procedures presently cannot avoid exposure to bone dust, blood and body fluids. Direct droplet contact by transport of viruses into the mouth, eyes or skin defects from accidental splashing or spattering of blood or body fluids is an ever present possibility in the autopsy room or embalming facility, and there is documentation of the transmission of the HBV from autopsy.
Traditional autopsy room clothing, consisting of scrub suits, shoe covers and surgical quality gloves, is not considered adequate for barrier protection. With the increased concern over HIV has come other recommendations for protective clothing for morgue and funeral home personnel. These include disposable jumpsuits that completely cover the body, hoods for the head and neck, safety goggles, double gloves and shoe covers, all of water impermeable materials. Formerly, masks were work at the discretion of those involved in postmortem procedures. Now, all guidelines require that masks be worn, and the more stringent proposals suggest the wearing of plastic face shields to cover the entire face and neck or safety goggles with cushion seals or wrap-around goggles for eyeglass wearers. Longer gloves, double gloves and those with improved safety features, such as mesh gloves for cutting bone, are also recommended.
There are also recommendations for modifying procedures to minimize spatters that might generate aerosol droplets, and for handling tissues and organs. For example, one such recommendation addresses the need to minimize exposure to airborne droplets during opening the skull. It suggests that the entire head of the cadaver be enclosed in a large plastic bag during the use of a bone saw to open the cranium. A hole is made in the bottom of the bag for the operator to use a hand saw instead of an electric saw. However, the bag typically does not remain inflated, causing the saw to cut the bag.
There exists a need, therefore, for a device which provides protection against blood-borne viruses and other pathogens for personnel engaged in postmortem examination procedures.
There also exists a need for such a device which not only isolates the pathogen, but will also contain spills or splashes and prevent spatter and mist from reaching the worker.
There exists a further need for such a device which facilitates disinfection procedures within a defined, enclosed work area.
There exists a still further need for such a device which permits personnel to work with a minimum of uncomfortable, restrictive personal barriers.